MEDAX S.R.L. UNIPERSONALE
⚠️ High Risk
FEI: 3007648417 • San Possidonio, Modena • ITALY
FEI Number
3007648417
Location
San Possidonio, Modena
Country
ITALYAddress
Via Sandro Pertini 4, , San Possidonio, Modena, Italy
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2025 | 79GABNEEDLE, SUTURING, DISPOSABLE | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is MEDAX S.R.L. UNIPERSONALE's FDA import refusal history?
MEDAX S.R.L. UNIPERSONALE (FEI: 3007648417) has 1 FDA import refusal record(s) in our database, spanning from 10/22/2025 to 10/22/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. MEDAX S.R.L. UNIPERSONALE's FEI number is 3007648417.
What types of violations has MEDAX S.R.L. UNIPERSONALE received?
MEDAX S.R.L. UNIPERSONALE has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about MEDAX S.R.L. UNIPERSONALE come from?
All FDA import refusal data for MEDAX S.R.L. UNIPERSONALE is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.